Optimization of the Management of Non-Traumatic Intracerebral Hemorrhage (OPT-ICH)

NCT06802588 | Recruiting

• 1 other identifier: 2022_011
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief Summary

Intracerebral non-traumatic intraparenchymal hemorrhages (ICH) account for 15 to 20% of strokes. One third of the patients dies within the month following ICH, and survivors often experience residual disability with a high risk of recurrent ICH, other serious vascular events, and neurological complications such as epilepsy and dementia. Encouraging but preliminary data suggest a favorable trend in terms of survival rates in recent years. This is partly due to improved management of patients with ICH, which must be early (the concept of "time is brain") and carried out by expert personnel (medical and paramedical) in specialized units. The main objectives of the study are:

• To evaluate the management of patients with ICH in the acute phase within the University Hospital of Tours by analyzing the procedures adopted in the various relevant departments (neurovascular units, neurosurgery, medical or neurosurgical intensive care, geriatrics);
• To evaluate whether the systematic implementation of a dedicated protocol (see \*) for the management of patients with ICH is associated with a reduction in mortality and disability in the short and long term.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• mortality and disability

  Primary Outcome Measure Title: Modified Rankin Scale (mRS) Scores to Assess Disability and Mortality Description: The study will evaluate functional outcomes, disability, and mortality in patients with non-traumatic intracerebral hemorrhage. Functional outcomes will be measured using the modified Rankin Scale (mRS), which evaluates the degree of disability or dependence in daily activities. The mRS scores range from 0 (no symptoms) to 6 (death). Data will be summarized as the proportion of participants in each mRS category at 6 months and 2 years. Mortality will be assessed as the percentage of participants with an mRS score of 6.

  6 months, 2 years

Secondary Outcomes (1)

• Neuropsychiatric patient profile among the survivors

  6 months, 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult population with acute ICH

You may qualify if:

• aged over 18 years
• emergency admission to the University Hospital of Tours
• having an ICH on imaging performed upon admission (CT scan or MRI) at the University Hospital of Tours

You may not qualify if:

• \- Patient who has given their opposition to the collection of their data

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

University Hospital of Angers

Angers, 49100, France

RECRUITING

University Hospital of Poitiers

Poitiers, 86000, France

RECRUITING

University Hospital Center of Tours

Tours, 37044, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

routine blood samples

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco PASI, MD, PHD

  neurovascular unit, neurology department, CHRU Tours

  PRINCIPAL INVESTIGATOR

• Grégoire Boulouis, MD, PHD

  interventionnal neuroradiology unit, neuroradiology department, CHRU Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco PASI, MD, PHD

CONTACT

+33 0247478024; M.PASI@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 31, 2025
• Study Start: May 1, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)